Document Control Training-1

7/27/2019 Document Control Training-1

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Presented By:

Engr. Lyne Lerin-Osorio

(QMR)

DOCUMENTCONTROLBasics of Good Documentationand Document Control Systems


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Course Objectives:

To enable participants to understand the basics of gooddocumentation.

To understand the ISO 9001:2000 requirements onControl of Documents and Control of Records.

To enable participants to deploy an efficient andeffective document control in their respective processesin accordance to the established Document ControlProcedure of NTC.


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Course Content

Unit 1 Basics of Good Documentation

Unit 2 QMS Requirements for Document

Control and Records Control

Unit 3 Life Cycle of Documents

Unit 4 Complying the Requirements

Unit 5 Managing Document Requests

Unit 6 Developing and Implementing theDocument Control Procedure

Unit 7 Checking the Level of Understanding


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Basics of Good

Documentation

Unit 1


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Step One in Building anEffective System is:

To Have Good

Documentation!


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Good Documentation is:

Clear

Concise

User friendly


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Avoid Drowning in Detail..

The purpose of this procedure is to documentthe aforementioned activities, herein after

referred to as the prescribed tasks in terms that

preclude their execution in an inconsistent

manner, wherein such inconsistency may

potentially result in the prescribed tasksdelivering a result that is not repeatable or

reproducible


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And poorly written procedures

Why use ten words when one will do?

The items hereinunder referenced in some

cases fell excessively outside normalparameters.

The procedures contained herein

are applicable to all operations in thefollowing departments within their

functional ambit


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Make procedures user friendly

Use short sentences starting with a verb.

Avoid using the passive voice. Make it

clear who is performing the task.

Use white space for easy reading.


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Have the Right Amount

of Documentation

But how much

documentation do Ineed?


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Avoid Creating too Much:

Work instructions written for virtually

everything

Overlap and repetition - Including a

process in more than one work instruction.


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Or too little:

Lack of work instructions where the

process affects the quality of the product.

Employees have their own way of

performing processes

There is variation in the process because

it is not well documented


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Documentation:

The right amount

Remember that the goal here is

consistencyfor your processes.

If two trained employees were to perform

this task, would they do it the same way?

If the answer to this is Maybe not a work

instruction is appropriate.


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Clarify Your Terminology:

Procedure

Work Instruction

Attachments Forms

Procedure: Describes the

process.

Work Instructions: Tells

how to perform theprocess.

Attachment: Information

attached to the procedure

to help clarify the

procedure.


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QMS REQUIREMENTS

FOR DOCUMENTCONTROL AND

RECORDS CONTROL

UNIT 2


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Unit 2 Summary

4.2.1 Documentation Requirements

QMS Documentation Structure

4.2.3 Control of Documents

4.2.4 Control of Records


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4.2.1 Documentation

Requirement - General

5 levels of Documentation

The quality management system documentation shall include

a. documented statements of a quality policy and quality objectives,

b. a quality manual,c. documented procedures required by this International Standard,

d. documents needed by the organization to ensure the effective planning,operation and control of its processes, and

e. records required by this International Standard (see 4.2.4).

NOTE 1 Where the term documented procedure appears within thisInternational Standard, this means that the procedure is established,documented, implemented and maintained.


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QMS Documentation Structure

QUALITY

POLICY

&

QUALITY OBJECTIVES

QUALITY MANUAL

STANDARD MANDATORY PROCEDURES

OPERATIONAL DOCUMENTS

RECORDS


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Six Mandatory Procedures

1. Control of Documents

2. Control of Records

3. Internal Quality Audit

4. Control of Nonconforming Products

5. Corrective Action

6. Preventive Action


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ISO 9001 Clause 4.2.3

CONTROL OF DOCUMENTS

Documents required by the quality

management system shall be controlled.

Records are a special type of documentand shall be controlled according to the

requirements given in 4.2.4.


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Clause 4.2.3

CONTROL OF DOCUMENTS

A documented procedure shall be establishedto define the controls needed

a. to approve documents for adequacy prior to issue,

b. to review and update as necessary and re-approvedocuments,

c. to ensure that changes and the current revision status

of documents are identified,d. to ensure that relevant versions of applicable

documents are available at points of use,


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Clause 4.2.4

CONTROL OF RECORDS

Records (A special type of document, 21 recordsneeded)

to provide evidence that system is being followedand is effective and meets ISO 9001

shall remain legible, readily identifiable and

retrievable.


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Clause 4.2.4

CONTROL OF RECORDS

A documented procedure shall be

established to define the controls needed;

Identification Storage

Protection

Retrieval Retention period

Disposition


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Reason for records

The reason to keep records is for

future use as a reference in case of

questions related to contractual and

legal matters, work techniques,

verification of work done, and other

parts essential to the company runningsmoothly.

The company management should use

sound judgment as to what records are

non-essential and how long to keep a

specific record.


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SECTION DESCRIPTION

4.2.1 General Reference to records required by

the standard

4.2.3 Control of documents For records are controlled according to

4.2.4

4.2.4 Control of records Records are established and maintained to

provide evidence of conformity

5.6.1 Management Review General

Management Review records

6.2.2 Competence, Awareness,

and Training

Education, training, skills, and experience

7.1 Planning a product realization Evidence is recorded that the realization

processes and resulting product meet

requirements

7.2.2 Review of requirements

related to the product

Results of the review and actions are

rising from the review


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SECTION DESCRIPTION

7.3.2 Design and development

inputs

Inputs relating to product

requirements

7.3.4 Design and developmentreview

Results of the reviews and any necessaryactions

7.3.5 Design and development

verification

Results of the verification and any

necessary actions

7.3.6 Design and development of

validation

Records of the results of validation and

any necessary actions

7.3.7 Control of design and

development changes

Results of the review of changes in any

necessary actions

7.4.1 Purchasing process Results of supplier evaluations and any

necessary actions are rising from the

valuation

7.5.2 Validation of processes for

production and service provision

Requirements for records as applicable

SECTION DESCRIPTION


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SECTION DESCRIPTION

7.5.3 Identification and

traceability

Where traceability is a requirement,

the unique identification of the

product

7.5.4 Customer property Records of customer property thatHas been lost, damaged, or unsuitable for use

7.6 Control of monitoring

and measuring devices

Where no standards exist, bases used for

calibration is recorded

Records of the results of calibration and

verification are maintained8.2.2 Internal audit Records of audit results

Implied records for reporting verification follow

up activities and results8.2.4 Monitoring and

measurement of product

Records indicates the person(s) authorizing the

release of the product

8.3 Control of non-

conforming product

The nature of nonconformities and any subsequent

actions taken, including concessions obtained

8.5.2 Corrective action Records for corrective action results taken

8.5.3 Preventive action Records for preventive action results taken


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ISO 9004

Guidelines for

Performance Improvements

The generation, use and control of

documentation should be evaluated withrespect to the effectiveness and efficiency

of the organization against criteria.


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ISO 9004 : Guidelines for

Performance Improvements

These criteria are:

Functionality (such as speed of processing),

User-friendliness,

Resources needed,

Policies and objectives,

Current and future requirements related to

managing knowledge,

Benchmarking of documentation systems, and

Interfaces used by organizations customers,

suppliers, and other interested parties.


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Documents vs. Records

There is often aconfusion between

Documents and Records


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Definition of Document

ISO 9001:2000

Meaning data and its supporting medium.

Note: The medium can be paper, magnetic,

electronic or optical computer

disc, photograph or mastersample or a combination thereof.


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Definition of Records

ISO 9001:2000

Stating results achieved or providing

evidences of activities performed.


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Documents Records

ISO 9001 clause 4.2.3 applies ISO 9001 clause 4.2.4 applies

Prescriptive:

Tells you What/when/ who/where/how to do

Descriptive:

Tells you what has been done.

Establish conformance to QMS

Document Process Activity Records

Input information Output information


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However

a document may evolve into a record


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Examples:

Document Record

PurchasingOrder/

Contracts

Beforegoods/services are

delivered

Aftertransactions are

completed

Procedure While still current When obsolete

and archivedForms Before it is used After it is used

(filled up)


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Requirements

Control of Document i.e. the requirement

to be revision

controlled

Control of Records i.e. the

requirements to

have a retentionperiod


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Controlled Documents

Documents for which there are specifiedrequirements on:

Initiation

Review Approval

Registration

issuance

Revision Obsolescence

withdrawal

(not all need apply)


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Control Methods

The recipients are identified and updated

when changes occur.

Control status highlighted on the

document.

User shall not make own copies.


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LIFE CYCLE OF

DOCUMENTS

UNIT 3


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Unit 3 Summary

Document Life Cycle

Document Control Flow Internal

Document Control Flow - External


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Document Life Cycle

Creation

Approval

Issue

Update/Change

Approval

Removal

Archiving

D t C t l Fl I t l


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Document Control Flow Internal

(Management/Process Owner) Review the need to initiate/update document

(Process Owner/Originator) Draft new/revised document

(Reviewer)Review for adequacy

(Approving Officer)Approve

(Document Controller/Administrator)Update/Register

(Document Controller/Administrator)Make Copies

(Document Controller/Administrator)Distribute/Withdraw

(Process Owner/User) Acknowledge

(Process Owner/User)Update/Register/Withdraw

(Process Owner/User)Use and Maintain


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Document Control Flow External

(User/Process Owner/Administrator) Receive

(Document Controller/Administrator) Update/Register

Copy

(Document Controller/Administrator)Distribute/Withdraw

(Process Owner/User)Acknowledge

(Process Owner/User) Update/Register/Withdraw

(Process Owner/User)Use and Maintain

(Document Controller/Administrator)


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COMPLYING WITH THE

REQUIREMENTS

UNIT 4


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Unit 4 Summary

Document Control

Roles and Responsibilities

Availability of Documents

Masterlist and Revision Status

Document Numbering System


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What is Document Control?

It is actually the control ofinformation

Increasing awareness in many organizations

Misunderstood the requirements

Overdone : cost of labor, time, paper

Not enough : cost of using outdated, wrong

information Non-conformities often raised against, during

Quality System Audit

It is


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How elaborate should a

Document Control System be?

It depends on:

Organization size and hierarchy

Organization culture

Number of locations (branches/field sites)

Resource availability (e.g. full time Document

Controller)

Technology (paper-based vs. online paperlesscontrol

Confidentiality and security classification


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Defining Roles and Responsibilities

ExamplesPrepare Review Approve Administer

Quality

Manual

QMR/

Dept Head

QMR MD/CEO Doc.

Controller

Procedures QMR/

Dept Exec +

QMR/

Dept Head

MD/CEO Doc.

Controller

SupportDocuments QMR/Dept Exec +QMR/Dept Head QMR/Dept Head Dept Head


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Availability of Documents

Pertinent Issues (not necessarily the latestissues)

Appropriate documents (not necessary all)

At all locations where operationsessential to the effective functioning of thesystem are performed

Usually at place of work, or within reasonableaccess

Not necessarily for every worker to get acopy!


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Chosen to reflect originating function (department),

type of document and number series.

Example:XX-YY-ZZ e.g. QA-WI-01

XX = Department/Function Code e.g. QA, PU

YY = Type of Document e.g. QM, PR, WI, FOZZ = Serial running number


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Benefits:

Easy to identify

document ownership

and scope ofapplication

Groups and indexes

QMS documents for

easy reference

M t li t f D t


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Masterlist of Documents

and Revision Status


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MANAGING DOCUMENTCHANGES

UNIT 5


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Unit 5 Summary

Updating Document Changes

Identifying Changes in Document

Duplication of Documents

Obsolete/Invalid Documents

Documents on Electronic Media

Control of Documents

Maintaining the Validity of Documents

Code of Practice in Using Documents


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Updating Document Changes

Update by replacing the entire document

Update by replacing only the affected sections

Use only a Change Notice to be attached to

the relevant document

Can be further classified as:

Minor change Major change

Id tif i Ch i


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Identifying Changes in

Document Use underline andit ali c sto highlight the

additions

Use strikethrough, shading , to highlight

obsolete information Use revision history log to indicate the changes

Use symbols ( ) to highlight changed

specification

Make reference to relevant Document Request

Record


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Preventing Unauthorized


Color stamps toindicate controlledissue

Watermark feature

Special paper (coloror grade)

Color printer

If stored on-line,disable the printfeature


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Preventing Unauthorized


Intentions:

Highlight awareness to prevent causalduplication

To guard against fraud/sabotage/theft


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Obsolete/Invalid Document

Obsolete

being superseded, or reach expirydate

Invalid wrong, unauthorized, illegal, etc.

Disposition options forobsoletedocuments: Mark and file for reference Mark and recycle paper

can be done by users directly or retrieved byDocument Controller

If recycled need to mark obsolete

If retained should specify retention period


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Document on Electronic Media

Additional controls which may be required:

Protection against data corruption, virus, (back-

up, antivirus scan) Unauthorized read/write access (password

protection)

Authentication of user ID Audit trail (log) of access transaction


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Electronic System

Allows effective centralized document control.

All past and current documents in one location.

Ease of revision and editing process allows quality

team to focus on improvement rather than

maintenance of paper documents.

Easy access to document reviewers and

approvers list.


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Electronic System

Allows effective centralized document control

Automatic document routing (Review/Approval)

Automatic notification of Changes.

Accurate reflection of approval time and date


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Electronic System


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Electronic System

C t l f A li ti S ifi


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Control of Application-Specific

Document

Best dealt within the procedure or workinstruction for that process.

Examples: Purchasing documents via Purchasing

Procedure

Audit Schedule via Internal Quality Audit

procedure. Quotation/Proposal via Order Inquiry and

Processing procedure.

C d f P ti i U i


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Code of Practice in Using

Documents

Should be intact.

Printed on appropriate material.

No unauthorized copying ofcontrolled

issue

Able to identify who authorize the issuance.

C d f P ti i U i


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Code of Practice in Using

Documents

Able to identify issue/revision status

Obsolete ones should be destroyed or

stamped/marked

Dont remove from designated reference

location


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Maintaining Validity of Documents

Changes (addition, removal, modification) in

Organization structure, responsibility

Process, products, services

Reference standards, specifications,customer requirements

should trigger review of relevantdocumentation.


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Maintaining Validity of Documents

Owner and users should proactively

review and update.

Internal/external audit must also look into

it!

Do what you right, write what you do???

DIFFERENCE BET CONTROLLED


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DIFFERENCE BET. CONTROLLED

AND UNCONTROLLED DOCUMENT

CONTROLLED Controlled documents are appropriately marked with

Master copy, Controlled Copy, Uncontrolled Copy,ISSUED. These are properly controlled thru documentcode, revision no. and effectivity date, stamping,

signatures and distribution log (master list).

Uncontrolled Copy controlled document stamped withUncontrolled Copy which is issued for information purposesonly and will not be updated with any revision.

Controlled Copycontrolled document stamped with ControlledCopy and issued to authorized registered holders and will beupdated whenever there are revisions.



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Uncontrolled Documents Uncontrolled documents are those documents that are not physically

within the current hard copies and do not have proper controlattached to it. It includes the proposed format (draft) of new orrevised documents that may be in soft or hard copy, photocopy ofmanuals.

Note: Internal or local controlled documents may not be controlledas prescribed provided it will not be kept as quality record.

Draft =proposed new/revised documents that is not stamped witheither controlled copy or uncontrolled copy but is appropriatelymark as DRAFT



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QUESTIONS TO ASK WHEN DETERMINING WHETHER A DOCUMENTSHOULD BE CONTROLLED:(procedures, work instructions and forms) Does the document guide the production of products provided by the

organization?

Does the document guide the verification, inspection or testing of products

provided by the organization? Does the document define customer and/or product requirements?

Is the document used for controlling processes?

Is the document used for decision making by the production personnel?

Is the document used for collecting data that could be used later for decisionmaking within the scope of QMS

Is the information on the document is so critical that failure to keep it updated

would pose a risk to the organization or its customers? Does the document address or relate to requirement from the ISO 9001:2000

If the answer to one or more of these questions is yes, then thedocument should be controlled.



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CONTROLLING FORMS

All forms must include:

Document Code

Title

Revision No.

Effectivity Date

NOTES:

Information written shall be legible. In case of alterations/erasures, a single lineacross the word's) and shall be initialed. Pentel Pen & pencil are not allowed in fillingup a form.

Rewrite damage form.

Only relevant versions of form shall be used in the process.

Controlled format & requirements shall not be modified.

Must be properly filled up.

If the old version may be used as scratch, put an X across the page and used theback portion of the form.

INADVERTENT USE OF


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INADVERTENT USE OF

OBSOLETE DOCUMENTS:

Updated Master list of Internally generateddocuments

Distribution list

NOTES:

Document controller must ensure the

distribution of Document to determine the

location of obsolete document.

MODES IN FILING DOCUMENTS:


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MODES IN FILING DOCUMENTS:

Chronological arrangementaccording to Date

Alphabetical arrangement

from A to Z or vice-versa

Numerical arrangementaccording to control number

Subject arrangementaccording to name.

Mostly applied to suppliers.


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DEVELOPING THE

DOCUMENT CONTROLPROCEDURE

UNIT 5


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UNIT 5 Summary

Common Problems with Document Control

Things to Consider in Developing the

Procedure

NTC Document and Records Control

System


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Common Problems with

Document Control


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Common Problems

Employees writing documents do notunderstand the difference between a Procedure

and a Work Instruction.

Terminology has not been defined, and is notused in a consistent manner.

Revisions take too long, documents are not kept

current.


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Common Problems

There is no process for tracking changes

or training on changes

Inconsistent use of other documents suchas:

forms

attachments

drawings documents of external origin


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Common Problems

Approval

Distribution

Keeping distribution

current


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Common Problems

Too many documents are

distributed. The system

cannot be maintained.

Lack of control of

documents of External

Origin.

Avoid these problems by planning ahead...

And All the pieces will fall


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And All the pieces will fall

in place.


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Unit 5 Workshop

Objective: To know and provide solutions to the commonproblem encountered in the implementation of DocumentControl.

Description: The class will be divided into groups. Theirtask is to identify, by brainstorming the top two problemsthey are encountering in the implementation of documentcontrol and to come up with solutions on how to addresssuch problems. A representative of each group will

discuss their output to the rest of the class.

Duration: 15 minutes preparation, 10 minutespresentation

Things to Consider in Developing


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Things to Consider in Developing

the Procedure

Ensure the Document Control Proceduremeets ISO 9001 requirements.

Make use of the Document Change

Request Form you designed earlier in theprocedure.

Ensure that the controls for the problems

discussed were included in the procedure. Remember, it is a system-wide procedure,

therefore, cascade it to all process owners.

NTC Document and Records Control System


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DOCUMENT AND CONTROL


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CHANGES

Identify Improvement

and/or Amendment tothe Quality System

Prepare Draft of the

Improvement or

Amendment

Fill up DCRFFill up DCRF

Submit DCRF and its

attachment to Document

Controller for

Review and Approval
http://localhost/var/www/apps/conversion/tmp/scratch_10//NKYMPDC/QMS_documentation/NTC%20Quality%20System%20Internal%20Documents/PROCEDURE%20MANUAL/DOCUMENTS%20&%20RECORDS%20CONTROL/forms/fm1_document%20changeform_4.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_10//NKYMPDC/QMS_documentation/NTC%20Quality%20System%20Internal%20Documents/PROCEDURE%20MANUAL/DOCUMENTS%20&%20RECORDS%20CONTROL/forms/fm1_document%20changeform_4.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_10//NKYMPDC/QMS_documentation/NTC%20Quality%20System%20Internal%20Documents/PROCEDURE%20MANUAL/DOCUMENTS%20&%20RECORDS%20CONTROL/forms/fm1_document%20changeform_4.pdf


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CHECKING THE LEVELOF UNDERSTANDING

UNIT 6


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Clause 4.2.3 Control of Document

Documents related to the Standard +External documents

Control Procedures establish document

and maintain

Documents review and approve prior to

issue for new and changes


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Clause 4.2.3 Control of Document

Current revision status/changes are identified

Pertinent Issues available

Document remain legible and readily

identifiable Obsolete documents remove or identify


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What are your Concerns?

What are your Views?